- Approval Id
- 77d96d9ad35905d7
- Drug Name
- GUTRON TABLET 5 mg
- Product Name
- GUTRON TABLET 5 mg
- Approval Number
- SIN11500P
- Approval Date
- 2001-04-28
- Registrant
- CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED
- Licence Holder
- CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- **DOSAGE AND ADMINISTRATION**
Adults and adolescents (>18 years): Initial dose 2.5 mg 2–3 times a day. The maximum recommended dose should not exceed 30 mg daily.
Treatment should be started under close medical supervision in a controlled clinical setting such as in hospital, in clinic, or in office. Hourly measurements of blood pressure (supine and sitting) should be made for 3 hours after the first dose and also the second dose of a three times daily dosage regimen.
This procedure should be followed also when the dose is increased. During the period of close medical supervision, the patient or a person living with the patient should be trained to measure blood pressure.
Supine and sitting blood pressures should be measured daily for at least one month after the initiation of treatment and twice per week afterwards. The administration of midodrine should be stopped and the attending physician notified immediately, if blood pressure in either position increases above 180/100 mmHg. It is recommended that treatment begins at the lowest level and be titrated at weekly intervals in small increments until the optimal response is obtained.
Dosing should take place during the daytime hours when the patient needs to be upright pursuing the activities of daily life. A suggested dosing schedule of approximately 4-hour intervals is as follows: shortly before or upon arising in the morning, midday, and the late afternoon (not later than 6 P.M.).
Doses may be given in 3-hour intervals, if required, to control symptoms, but not more frequently.
Single doses as high as 20 mg have been given to patients, but severe and persistent systolic supine hypertension occur at a high rate (about 45%) at this dose. In order to reduce the potential for supine hypertension during sleep, GUTRON should not be given after the evening meal or less than 4 hours before bedtime. Total daily doses greater than 30 mg have been tolerated by some patients, but their safety and usefulness have not been studied systematically or established. Because of the risk of supine hypertension, GUTRON should be continued only in patients who appear to attain symptomatic improvement during initial treatment.
The supine and standing blood pressure should be monitored regularly, and the administration of GUTRON should be stopped if supine blood pressure increases excessively.
Because desglymidodrine is excreted renally, dosing in patients with abnormal renal function should be cautious; although this has not been systematically studied, it is recommended that treatment of these patients be initiated using 2.5 mg doses.
Dosing in children has not been adequately studied. Blood levels of midodrine and desglymidodrine were similar when comparing levels in patients 65 or older vs. younger than 65 and when comparing males vs. females, suggesting dose modifications for these groups are not necessary.
- Route Of Administration
- ORAL
- Indication Info
- **INDICATIONS**
For treatment of idiopathic / neurogenic orthostatic hypotension.
The Indication is based on GUTRON effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit.
At present, however, clinical benefits of GUTRON principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of GUTRON.
After initiation of treatment, GUTRON should be continued only for patients who report significant symptomatic improvement.
Because midodrine can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care including nonpharmacologic treatment (such as support stockings), plasma volume expansion and lifestyle alterations.
- Contraindications
- **CONTRAINDICATIONS**
GUTRON is contraindicated in patients with the following conditions/diseases:
- Severe organic heart disease (e.g: bradycardia, ischaemic heart disease, congestive heart failure, cardiac conduction disturbances or aortic aneurism)
- Hypertension
- Serious obliterative or spastic vascular disorders (e.g: cerebrovascular occlusions and spasms)
- Acute renal disease
- Severe renal impairment
- Hypertrophy of the prostate gland with residual volume increased
- Urinary retention
- Proliferative diabetic retinopathy
- Phaechromocytoma
- Hyperthyroidism
- Narrow-angle glaucoma
- Known hypersensitivity to any component of the product
GUTRON should not be used in patients with persistent excessive supine hypertension. GUTRON should not be used in vasovagal hypotension.
- Atc Code
- C01CA17
- Atc Item Name
- midodrine
- Pharma Manufacturer Name
- CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED
- Company Detail Path
- /organization/celltrion-healthcare-singapore-private-limited
